Hereditary Angioedema
Conditions
Interventions
Deucrictibant 20 mg or placebo will be administered orally during 2 HAE attacks as crossover treatment.
Sponsors
Yu Ming
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent/assent. 2. Male or female, aged >=12 to =12 and =40 kg. 9. Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.
Exclusion criteria
Exclusion criteria: 1. Any female who is pregnant, plans to become pregnant, or is breastfeeding. 2. Any diagnosis of angioedema other than HAE. 3. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study. 4. Use of attenuated androgens for short-term prophylaxis within 2 weeks before screening. 5. Abnormal hepatic function. 6. Abnormal renal function (eGFR <60 ml/min/1.73 m2). 7. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse. 8. Has received prior on-demand HAE treatment with deucrictibant. 9. Currently participating in any other investigational drug study or receiving other investigational treatment within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization. 10. Prior gene therapy for any indication at any time. 11. Use of concomitant medications with systemic absorption that are strong inhibitors of CYP3A4 or strong inducers of CYP3A4 within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization. 12. Known hypersensitivity to study drug or any of the excipients of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment. | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Netherlands, North Macedonia, Poland, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Turkey, United Kingdom, United States
Contacts
Public ContactNobuhiko Osawa
Medpace Japan K.K.
Outcome results
None listed